Efficacy of PegIntron (Peginterferon Alfa-2b) and Rebetol (Ribavirin) in Treatment-naïve Subjects With Chronic Hepatitis C in Clinical Practice in Greece (Study P05209)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00724464
First received: July 25, 2008
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

The objective of the study is to evaluate the rates of Hepatitis C virus (HCV) eradication and relapse in participants treated with PegIntron and Rebetol in clinical practice in Greece. Participants will not be treated as part of the study. Data on participants treated in accordance with approved labeling will be collected retrospectively from approximately 30 sites in Greece.


Condition Intervention
Hepatitis C, Chronic
Hepatitis C
Biological: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
Drug: Rebetol (ribavirin)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A Greek Observational Study on Relapse Rate and Sustained Virological Response in Naive CHC Patients, Treated With Pegylated Interferon Alpha-2b and Ribavirin in Daily Clinical Practice

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    Sustained virological response (SVR) was assessed at the 24-week post-treatment follow-up (Visit 2). SVR was defined as undetectable plasma Hepatitis C virus Ribonucleic acid (HCV-RNA) at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Demonstrated Virological Relapse as Assessed at 24-week Post-treatment Follow-up [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    Virological relapse was assessed at the 24-week post-treatment follow-up (Visit 2). Virological relapse was defined as undetectable plasma HCV-RNA at end of combination treatment (Visit 1- considered Week 24 or Week 48 after treatment start depending on treatment duration), but with positive HCV-RNA at the 24-week post treatment follow-up.


Secondary Outcome Measures:
  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV Genotype at Baseline [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV genotype (1, 2, 3, 4, or 2 & 3) at baseline. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Liver Fibrosis Stage at Baseline [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on liver fibrosis stage, where biopsy was available, at baseline: absence, minimal, moderate, or significant as assessed by investigator. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on HCV-RNA Viral Load at Baseline [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on HCV-RNA viral load at baseline as assessed by investigator. Low viral load was defined as <400,000 International Units/milliliter (IU/mL) and high viral load was defined as >=400,000 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Alanine Aminotransferase (ALT) Levels at Baseline [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on ALT levels at baseline as assessed by investigator. Normal baseline ALT level was defined as <40 IU/mL and elevated baseline ALT level was defined as >= 40 IU/mL. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Study Treatment Dosage Modification [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on study treatment dosage modification: no dosage modification or any dosage modification of study treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Achievement of Rapid Virological Response [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed at the 24-week post-treatment follow-up (Visit 2) by subgroups based on achievement of rapid virological response (RVR) where data was available. RVR was defined as negative HCV-RNA after 4 (+/- 1) weeks of treatment. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment (24 or 48 weeks of treatment duration).

  • Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up by Subgroups Based on Compliance With the 80/80/80 Rule [ Time Frame: 24 weeks following completion of 24 or 48 weeks of therapy ] [ Designated as safety issue: No ]
    SVR was assessed by subgroups based on compliance with the 80/80/80 rule where data was available. 80/80/80 compliant participants were those that received >= 80% of the planned total doses of both pegylated interferon alfa-2b & ribavirin for >=80% of the duration of therapy. 3 rates were to be computed: Compliance with study duration, compliance with pegylated interferon dose, & compliance with ribavirin dose. A participant was defined as compliant, if none of the 3 rates were < than 80%. SVR was defined as undetectable plasma HCV-RNA at 24 weeks after termination of combination treatment.


Enrollment: 332
Study Start Date: December 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants with Chronic Hepatitis C
Treatment-naïve participants with chronic hepatitis C, undergoing treatment with a standard treatment regimen of PegIntron and Rebetol in clinical practice at approximately 28 sites in Greece
Biological: PegIntron (peginterferon alfa-2b, pegylated interferon alfa-2b)
Prior to enrollment in the study, PegIntron was to be administered at a dose of 1.5 μg/kg/week subcutaneously in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.
Other Name: SCH 54031
Drug: Rebetol (ribavirin)
Prior to enrollment in the study, Rebetol was to be administered at a dose of 800-1200 mg/day orally in accordance with approved labeling. Therapy duration varied from 24 to 48 weeks depending on HCV viral load and genotype followed by a 24-week post-treatment follow-up.
Other Name: SCH 18908

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Treatment-naïve participants with chronic hepatitis C treated with PegIntron and Rebetol in accordance with approved labeling in clinical practice in Greece prior to enrollment in the current study. Data from patients treated at approximately 28 sites will be retrospectively analyzed.

Criteria

Inclusion Criteria:

  • Participants who have already begun Summary of Product Characteristics (SmPC)-based combination treatment with pegylated interferon alpha-2b and ribavirin, prior to the site initiation date.
  • Participants who have been receiving combination treatment with pegylated interferon alpha-2b and ribavirin for at least 6 months before enrollment.
  • Participants who have achieved negative HCV RNA at the end of treatment, defined according to genotype (24 weeks for HCV genotypes 2/3 and 48 weeks for genotypes 1/4).
  • Participants with diagnosed chronic hepatitis C (CHC) and HCV genotype 1, 2, 3 or 4.
  • Participants older than 18 years, regardless of gender or race.

Exclusion Criteria:

  • The participant has received treatment for CHC in the past (not treatment-naive).
  • The participant has received treatment in the context of a clinical trial in the participating site.
  • The participant has been diagnosed with a concomitant infection e.g. with hepatitis B or HIV
  • The participant has de-compensated liver disease or belongs to a special population, such as liver transplant, hemophilia, severe pre-existing psychiatric disorder, auto-immune disease, thalassaemia.
  • The participant has positive HCV RNA at the end of treatment.
  • Pregnant women or women intending to bear children or sexual partners of women wishing to bear children and for a 7-month period after the end of treatment, as indicated in the SmPC of Rebetol.
  • The participant is not eligible on grounds of contra-indications, special warnings, particular population and/or the section on pregnancy and lactation of the SmPC.
  • The participant has interrupted treatment for any reason.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00724464     History of Changes
Other Study ID Numbers: P05209
Study First Received: July 25, 2008
Results First Received: October 4, 2011
Last Updated: December 4, 2013
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferon-alpha
Interferons
Ribavirin
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014